Lamellar surgeries with SMILE-derived lenticules.

PURPOSE: Lamellar surgeries with SMILE lenticules are an evolving field of refractive surgery. This chapter intends to discuss the reported clinical results of using SMILE derived lenticules in terms of feasibility, safety and predictability; or the potential management of hyperopia, keratoconus, SMILE ectasia and presbyopia. MATERIALS AND METHODS: Donor SMILE lenticules were prepared under microscope tocreate doughnut shaped lenticules. For hyperopia, this tissue was then inserted into afemtosecond laser enabled pocket created using VisuMax FS Laser at a depth of 160µm. For ectasia induced by keratoconus and post refractive procedure (SMILE), 0.23% riboflavin dye was instilled into the interface and then lenticule was inserted followed by exposure to UV-A radiation with total energy of 6.3 J. RESULTS: Spherical equivalent (S.E.) of within ± 0.5 D was observed in 50% (n=21) eyes and within 1 D was seen in 71% eyes treated for hyperopia. A significant increase in the K mean anterior, central corneal thickness, Q-value and corneal aberrations was seen 2 weeks post-op. Clinical improvement in terms of S.E. and uncorrected distance visual acuity in eyes treated for ectasia after keratoconus and post refractive procedure (SMILE) was seen. CONCLUSION: With the ample availability of SMILE- derived lenticules, researchers are exploring the possibility of using this tissue for the treatment of various refractive and corneal conditions.

Clinical outcomes and rotational stability following implantation of a monofocal toric IOL with textured haptics in normal versus high axial lengths.

PURPOSE: To compare the clinical outcomes and rotational stability following implantation of a toric IOL with textured haptics in eyes with normal versus high axial lengths. STUDY DESIGN: Two-arm, retrospective comparative study. SETTING: Nethradhama Superspeciality Eye Hospital, Bangalore. METHODS: This retrospective study included 114 eyes of 114 patients who underwent femtolaser cataract surgery followed by implantation of the HOYA Vivinex Toric monofocal IOL (Model XY1A-SP), of which 62 and 52 eyes belonged to normal (=/<23.9 mm) and high (=/> 24mm) axial length groups respectively. One week and 3 months post-operatively, clinical outcomes and rotational stability of the toric IOL was evaluated. RESULTS: Three months post-op, % eyes achieving refractive astigmatism accuracy within ≤0.50 D, was 100% (n=62) in the normal versus 94% (n=49) in the high axial length group. All eyes i.e., 100% (n=62) in the normal and 96.15% (n=50) eyes in the high myopia group were <5º of the intended axis. The mean change in post-op rotation from 1 week to 3 months was 0.28 ±0.09º in the normal, and 0.30 ± 1.11º in the high axial length group, p=0.80. No significant correlation was observed between axial length and WTW diameter with 1-week post-op rotation values. No eye required re-positioning of toric IOL for significant misalignment. CONCLUSION: No significant differences were observed for clinical outcomes and post-op rotational stability between eyes with normal and high axial lengths, suggesting excellent rotational stability of the Vivinex Toric IOL with textured haptics in all eyes, irrespective of the pre-operative axial length measurements.

Changes in endothelial cell density following conventional phacoemulsification and femtosecond laser-assisted cataract surgery in eyes with dense cataracts.

PURPOSE: To compare the safety, effectiveness and changes in endothelial cell density following standard phacoemulsification and femtosecond laser-assisted cataract surgery (FLACS) in dense cataracts (LOCS III grade 3.0 NO and above). SETTING: Nethradhama Superspeciality Eye Hospital, Bangalore, India. DESIGN: Prospective, randomized, comparative study. METHOD: 100 eyes of 100 patients were randomly assigned to either conventional phacoemulsification surgery (CPS) or FLACS (LENSAR Laser System) using pre-defined patterns of nuclear fragmentations. Measured outcomes included intra-operative phaco time, irrigation fluid volume, surgical time and complication rates. Endothelial cell density was evaluated at baseline, 2 weeks and 6 months post-operatively. RESULTS: The CPS group had significantly higher mean total phaco time (TPT, 11.17 ± 6.5 sec vs 8.03 ± 3.77 sec), effective phaco time (EPT, 6.14 ± 3.62 sec vs 4.42 ± 2.07 sec) and total surgical time (8.18 ± 2.36 min vs 7.11 ± 1.55 min) than the FLACS group (p<0.001). Volume of irrigation fluid was comparable between the two groups (CPS, 36.7 ± 12.18 ml, FLACS, 38.64 ± 13.73 ml, (p =0. 45). Mean corneal oedema score and CCT values on POD-1 were significantly higher for the CPS group. At 6 months, % endothelial cell density (ECD) loss was significantly higher in the CPS group (16.08%) versus the FLACS group (12.8%), p <0.001. Three eyes in the CPS group had wound burns of varying severity. CONCLUSION: FLACS with customized nuclear fragmentation patterns resulted in significantly less intra-operative phaco time, surgical time and endothelial cell loss compared to conventional phacoemulsification when treating dense cataracts.

Central corneal distortion after small-incision lenticule extraction.

A 33-year-old woman with a prior history of small-incision lenticule extraction (SMILE) presented with gradual deterioration of vision in her right eye since the surgery. She had undergone bilateral SMILE for myopic correction (-7.00 diopters [D] in the right eye and -6.00 D in the left eye) 3 weeks prior. SMILE was performed with a Zeiss VisuMax femtosecond laser system, with a cap thickness of 120 µm, a cap diameter of 7.50 mm, and a lenticule diameter of 6.50 mm. At the completion of the surgery, loose epithelium was noted at the SMILE incision bilaterally, and bandage contact lenses were placed in both eyes. On the first postoperative day, the patient's uncorrected distance visual acuity (UDVA) was 20/40 in both eyes. The bandage lenses were removed from both eyes, with the epithelium intact. At the first-week postoperative visit, her visual acuity was recorded as 20/30 in the right eye and 20/20 in the left eye. She noticed her vision in the right eye was not as sharp as that in her left eye. She denied experiencing any pain, redness, or ocular surface irritations. She was advised to return to the clinic for a 1-month postoperative visit and continue with aggressive lubrication in both eyes. However, a week later, the patient returned for an emergency visit, citing significant central visual distortion in the right eye and difficulty working on the computer. At this visit, her UDVA and corrected distance visual acuity (CDVA) was 20/50 in the right eye and 20/15 in the left eye at both near and far distances. A slitlamp examination revealed mild central changes in the right eye. She once again denied any pain, redness, or irritation. She was advised to continue with artificial tears and return to the office in 1 week for further observation of the central distortion in her right eye. Upon returning to the clinic at the third postoperative week, the patient still complained of central visual changes in the right eye, with a visual acuity of 20/70. Further slitlamp examination revealed a nonspecific central haze in the same eye, but there was no corneal staining or signs of epithelial defects. Anterior segment ocular coherence tomography (AS-OCT) and NIDEK topography were performed, showing the same central distortion in the right eye (Figures 1 and 2JOURNAL/jcrs/04.03/02158034-202311000-00016/figure1/v/2023-10-18T004638Z/r/image-tiffJOURNAL/jcrs/04.03/02158034-202311000-00016/figure2/v/2023-10-18T004638Z/r/image-tiff). Based on the examination and images provided, what is your working medical diagnosis? What other medical conditions are in your differential diagnosis? What medical and/or surgical interventions would you recommend, if any?

The Ganesh-Grewal cystitome maker - A step in standardizing cataract surgery.

A well-centered, adequately sized continuous curvilinear capsulorhexis (CCC) is a prerequisite for successful cataract surgery. A perfect capsulorhexis ensures safe and effective performance of various steps of surgery as well as a correctly positioned intraocular lens (IOL) with optimal rotational stability. Ganesh and Grewal (GG) cystitome maker is a step toward standardizing the creation of a cystitome to reduce variations and complications associated with the crucial step of CCC in cataract surgery. We conducted a study to measure the repeatability and precision of cystitomes made by the GG cystitome maker versus those made manually with a needle holder. The results showed that the cystitomes made with GG cystitome maker had a lesser degree of variation. This indicates a more repeatable cystitome, which will inadvertently help in reducing the error caused by the instrument in making a good CCC during cataract surgery.

Interobserver agreement between central topography and Scheimpflug tomography for premium intraocular lens selection.

PURPOSE: To assess the inter-observer agreement and reliability of central topography (CT) of IOL Master 700 with that of Pentacam HR, as a screening tool for determining the suitability for premium (toric, monofocal and presbyopia correcting) intraocular lens (IOL) implants. SETTING: Nethradhama Superspeciality Eye Hospital, Bangalore, India. METHOD: 200 eyes of eligible patients undergoing unilateral or bilateral phacoemulsification with premium IOL's were included in the study. Preoperatively, IOL Master 700 CT and Pentacam scans were performed for corneal topography evaluation. 2 experienced clinicians were randomised to interpret the axial map of either of the scans at a time and their responses were then enclosed in an envelope, and forwarded to a third observer for analysis. If there was a conflict, final decision was based on the interpretation of the Pentacam scan. RESULTS: Of the total scans interpreted by the 2 observers, 77.5% (n = 155) showed agreement whereas 22.5% (n = 45) showed disagreement. The sensitivity, specificity, positive predictive value and negative predictive value (NPV) of IOL Master 700 CT in diagnosing irregular corneas when compared with Pentacam HR, was 72.73%, 78.09%, 29.09% and 95.86% respectively. The Cohen's κ inter-observer agreement value was 0.44, signifying a moderate degree of agreement, which was statistically significant (P < .00). CONCLUSIONS: High NPV of IOL Master CT suggested that the device efficiently ruled out irregular corneas, while any suspicious scan should be confirmed with Pentacam HR or a similar device for appropriate decision-making regarding premium IOL selection. TRIAL REGISTRATION NUMBER: CTRI/2021/11/038053.

A new intraocular lens marker to guide the implantation of toric intraocular lenses in small and mid-dilating pupils.

Insufficient pupillary dilatation is a significant challenge during cataract surgery, as it increases the risk of various intraoperative complications. Implantation of toric intraocular lenses (TIOL) is particularly difficult in eyes with small pupils, as the toric marks are provided in the periphery of the IOL optic, making the visualization of the same difficult for proper alignment. Attempts at visualizing these marks using a second instrument such as a dialler or iris retractor lead to additional manipulations in the anterior chamber resulting in increased chances of postoperative inflammation and intraocular pressure rise. A new intraocular lens (IOL) marker to guide the implantation of TIOLs in eyes with small pupils is described, which can potentially be beneficial in achieving accurate alignment of toric IOLs in small pupils, without the need for additional manipulations, thus improving safety, efficacy, and success rates of TIOL implantation in these eyes.

A prospective, randomized, comparative clinical study to compare the safety and efficacy of different hydrophobic aspheric monofocal intraocular lenses.

Purpose: To report the 1-year clinical outcomes related to safety, efficacy, predictability, contrast sensitivity, patient satisfaction, complications, and overall results with Optiflex Genesis and Eyecryl Plus (ASHFY 600) monofocal aspheric intraocular lenses (IOLs) and compare the same with Tecnis-1 monofocal IOL. Methods: This prospective, single-center, single-surgeon, randomized, three-arm study included 159 eyes of 140 eligible patients who underwent cataract extraction with IOL implantation with any of the three study lenses. Clinical outcomes related to safety, efficacy, predictability, contrast sensitivity, patient satisfaction, complications, and overall results were compared at a mean follow-up of 1 year (12 ± 1.20 months). Results: Preoperatively, age and baseline ocular parameters of all the three groups were matched. At 12 months post-op, no significant differences were noted among the groups in terms of mean postoperative uncorrected and corrected distance visual acuity (UDVA and CDVA, respectively) sphere, cylinder, and spherical equivalent (SE; P > 0.05 for all parameters). Eighty-nine percent eyes in the Optiflex Genesis group as against 96% eyes in the Tecnis-1 and Eyecryl Plus (ASHFY 600) groups were within ± 0.5 D, and 100% of eyes in all the three groups were within ± 1.00 D of SE accuracy. Postoperative internal higher-order aberrations (HOAs) and coma, and mesopic contrast sensitivity at all spatial frequencies were comparable across all the three groups. Two eyes in the Tecnis-1 group, two eyes in the Optiflex group, and one eye in the Eyecryl Plus (ASHFY 600) group underwent YAG capsulotomy at the last follow-up. No eye in any of the groups showed glistenings or required IOL exchange due to any reason. Conclusion: At 1-year post-op, all the three aspheric lenses showed comparable results in visual and refractive parameters, post-op aberrations, contrast sensitivity, and posterior capsule opacification (PCO) behavior. Further follow-up is needed to evaluate the long-term behavior for refractive stability and PCO rates of these lenses. Trial registry: CTRI/2019/08/020754 (www.ctri.nic.in).

Twelve-Months Follow-Up Postmarket Study of a Hydrophobic Intraocular Lens Using a Preloaded Automated Injector in an Indian Population.

Purpose: To assess real-world clinical outcomes and safety of the Clareon® intraocular lens (IOL) and AutonoMe® automated preloaded delivery system in an Indian population. Patients and methods: This was a prospective, single-arm, multicenter, 12-month clinical study in patients aged ≥20 years with unilateral or bilateral cataracts. Surgery was performed by phacoemulsification followed by implantation of the Clareon monofocal IOL (CNA0T0). Monocular best-corrected distance visual acuity (BCDVA) and uncorrected distance visual acuity (UCDVA) were assessed at 1 week and 1, 6, and 12 months after implantation. Posterior capsular opacification (PCO), surface haze, and glistenings were evaluated at all visits. Surgeons' satisfaction with automated injector system was also evaluated using a questionnaire. Safety was assessed by monitoring adverse events (AEs). Results: A total of 151 eyes received the CNA0T0 IOL. Mean ± SD monocular BCDVA improved from 0.53±0.44 logMAR preoperatively to 0.00±0.08 logMAR at week 1 and -0.03±0.08 logMAR at 12 months after implantation. At 12 months, 137/137 (100%) of eyes achieved BCDVA of 0.3 logMAR or better. Mean ± SD monocular UCDVA was 0.78±0.40 logMAR preoperatively, 0.11±0.15 logMAR at week 1, and 0.08±0.13 logMAR at 12 months after implantation. At 12 months, 132/137 (96%) eyes achieved UCDVA of 0.3 logMAR or better. Serious intraoperative AEs were posterior capsule rupture (n=1) and ciliary zonular dehiscence (n=1). Surgeons reported that the automated preloaded device was more intuitive compared with other push- or screw-style preloaded injector systems. None of the eyes in this study presented surface haze; all were graded as 0 glistenings at all visits. No clinically significant PCO or neodymium-doped yttrium aluminum garnet (Nd:YAG) capsulotomies were reported. Conclusion: The hydrophobic IOL preloaded in an automated injector system provided good visual and refractive outcomes, as well as no surface haze and grade 0 glistenings. None of the patients required Nd:YAG capsulotomy.

SMILE for Hyperopia With and Without Astigmatism: Results of a Prospective Multicenter 12-Month Study.

PURPOSE: To investigate the safety and effectiveness of small incision lenticule extraction (SMILE) in patients who have hyperopia with or without astigmatism. METHODS: This was a prospective multicenter trial including 374 eyes of 199 patients treated by SMILE for hyperopia using the VisuMax femtosecond laser (Carl Zeiss Meditec AG). Inclusion criteria were sphere up to +6.00 diopters (D), cylinder up to 5.00 D, and maximum hyperopic meridian up to +7.00 D, with preoperative corrected distance visual acuity (CDVA) of 20/25 or better. The optical zone was 6.3 mm with a transition zone of 2 mm. The minimum lenticule thickness was set at 25 µm in the center and at 10 µm at the edge. Patients were examined at 1 day, 1 week, and 1, 3, 6, 9, and 12 months after surgery. Standard refractive surgery outcomes analysis was performed. RESULTS: The preoperative spherical equivalent was +3.20 ± 1.48 D (range: +0.25 to +6.50 D). At the 12-month follow-up visit, 81% of eyes treated were within ±0.50 D and 93% of eyes were within ±1.00 D of intended correction. A total of 1.2% of eyes lost two or more lines of CDVA at the 12-month follow-up visit, and 83% were at least 20/20, corresponding to a safety index of 1.005 at 12 months. Of the 219 eyes with plano target, 68.8% had an uncorrected distance visual acuity of 20/20 or better and 88% were at least 20/25 uncorrected at 12 months. There were no statistically significant changes in contrast sensitivity. CONCLUSIONS: SMILE was found to be an effective treatment method for the correction of compound hyperopic astigmatism, demonstrating a high level of efficacy, predictability, safety, and stability. [J Refract Surg. 2022;38(12):760-769.].

Corneal opacities after small-incision lenticule extraction.

A 36-year-old woman was referred to our clinic in October 2021 with suboptimal vision at intermediate and near distances and halos and photophobia after a small-incision lenticule extraction (SMILE) in December 2019. The patient needs to increase font size of her computer to 150% to read text, but images still appear blurred. She indicates that sunglasses seem to improve her contrast. Preoperatively, her refractive error was -2.5 diopters (D) and -2.25 D for right and left eyes. The optical zone size of the SMILE procedure was 6.8 mm. There is no further information available on the peroperative course of the SMILE procedure. Her uncorrected distance visual acuity (UDVA) is 20/20 in both eyes and does not improve with correction. The Schirmer tear test is 14 to 13 mm. Slitlamp biomicroscopy of the right eye and the left eye reveals hyperreflective small opacities in the anterior one-third of the corneal stroma ( Figures 1 and 2JOURNAL/jcrs/04.03/02158034-202209000-00021/figure1/v/2022-08-29T115553Z/r/image-tiffJOURNAL/jcrs/04.03/02158034-202209000-00021/figure2/v/2022-08-29T115553Z/r/image-tiff ). No other abnormalities are seen. The scotopic pupil sizes are 6.41 and 6.73 mm. Straylight measurements are within normal limits. Higher-order aberrations (HOAs) measure for the right eye (6.03 mm pupil) 0.818 µm and for the left eye (6.17 mm pupil) 0.560 µm. The corneal Scheimpflug tomography quad maps for both eyes are shown in Supplemental Figures 1 and 2 ( http://links.lww.com/JRS/A663 , http://links.lww.com/JRS/A664 ). What is your diagnosis or are additional diagnostic methodologies needed to establish a diagnosis? What is your treatment advice for this patient?

Femtosecond Intrastromal Lenticule Implantation (FILI) for Management of Moderate to High Hyperopia: 5-Year Outcomes.

PURPOSE: To report the long-term clinical experience following femtosecond intrastromal lenticule implantation (FILI) for the management of moderate to high hyperopia. METHODS: Eligible patients who underwent FILI for moderate to high hyperopia from July 2013 to October 2020 were included. A donor small incision lenticule extraction lenticule, matched for refractive error, was implanted into the recipient's corneal pocket created using a femtosecond laser at 160 µm depth. Visual and refractive outcomes and long-term complications were evaluated at the end of a mean follow-up of 68 ± 17.28 months (5.6 years). RESULTS: Forty-two eyes of 25 patients (mean age: 27.29 ± 5.52 years) were analyzed. The mean spherical equivalent reduced significantly from +5.50 ± 1.96 to +0.66 ± 1.17 diopters (D) at last follow-up visit. Thirty eyes (71%) were within ±1.00 D of spherical equivalent correction. Cumulative uncorrected distance visual acuity of 20/40 or better was achieved in 34 eyes (81%). Efficacy and safety indices were 0.86 ± 0.19 and 1.17 ± 0.39, respectively. There was a significant increase in mean keratometry (Kmean) anterior, central corneal thickness, Q-value, and corneal higher order aberrations and a decrease in Kmean posterior 2 weeks postoperatively, without any significant change in these parameters thereafter (P > .05). Four eyes of 3 patients underwent enhancement and another 4 eyes underwent explantation of the lenticule followed by exchange (2 eyes) and hyperopic laser in situ keratomileusis (2 eyes). No eye lost more than one line of CDVA. CONCLUSIONS: At 5 years of follow-up, FILI for moderate to high hyperopia showed good safety, efficacy, and reversibility. Modification of nomograms and surgical planning may be employed for further refinement of the outcomes. [J Refract Surg. 2022;38(6):348-354.].

Comparison of Long-Term Outcomes and Refractive Stability following SMILE versus SMILE Combined with Accelerated Cross-Linking (SMILE XTRA).

Purpose: To compare the long-term safety, efficacy, predictability, and refractive stability following SMILE versus SMILE combined with accelerated cross-linking (SMILE XTRA), and to specifically study the regression patterns following the two procedures. Methods: This retrospective study included 54 eyes of SMILE and 54 eyes of SMILE XTRA treated for normal and borderline cases of myopia/myopic astigmatism, respectively, based on certain predefined topographic features and risk factors. Patients in both the groups were matched for age and refractive error. The mean postoperative follow-up for the SMILE group was 22.18 ± 10.41 months and the SMILE XTRA group was 21.81 ± 10.19 months. Results: At the end of follow-up, the mean sphere, cylinder, and SE reduced to -0.03, -0.09, and -0.08 D in the SMILE group and -0.06, -0.15, and -0.13 D in the SMILE XTRA group. 96% and 93% eyes remained within ±0.50 D in SMILE and SMILE XTRA groups, respectively, and 94% eyes maintained an UDVA of 20/20 or better in the SMILE as well as SMILE XTRA groups. Safety and efficacy indices for the SMILE group were 1.03 and 1.00. For the SMILE XTRA group, the safety and efficacy indices were 1.00 and 0.99. No eye in either group had postoperative ectasia or enhancement performed for significant residual refractive error. Conclusion: Both the SMILE and SMILE XTRA groups exhibited comparable visual outcomes, safety, and efficacy. Contrary to the belief, combination of prophylactic CXL with SMILE did not result in a hyperopic shift in the long term. No eye in either group encountered postoperative ectasia; however, further follow-up is suggested to establish the long-term effects on refractive and corneal stability following SMILE XTRA, as all the eyes treated in this group were borderline.

Phaco with ICL in situ in a case of high hyperopia.

PURPOSE: To describe a unique method of biometric calculation and surgical technique of phacoemulsification and posterior chamber intraocular lens (PCIOL) implantation with an implantable collamer lens (ICL) in situ; for a high hyperope with post - ICL cataract. OBSERVATIONS: A patient with high hyperopia who underwent bilateral ICL implantation later developed cataract in both eyes. He underwent phacoaspiration of the cataract with ICL in situ and a standard power PCIOL implantation in the left eye. A unique method of PCIOL power calculation was later devised for the right eye by accounting for the residual refractive error of the eye and implanted by a similar surgical technique. CONCLUSION AND IMPORTANCE: Following cataract surgery with the ICL in situ, the patient had a residual refractive error of +3.00D in the left eye however had a minimal residual refractive error in the right eye. A new surgical method of PCIOL implantation after cataract extraction with an ICL in situ as well as the biometric calculation for a PICOL to be implanted with an ICL in situ was devised.

Long-term Outcomes of Bowman's Membrane Relaxation for Enhancement of Femtosecond Intrastromal Lenticule Implantation Performed for the Management of High Hyperopia.

PURPOSE: To evaluate the feasibility and report long-term outcomes with Bowman's membrane relaxation (BMR) for enhancing the residual refractive error following femtosecond intrastromal lenticule implantation (FILI). METHODS: BMR was performed using a Hessburg-Barron trephine to create a circular incision into the Bowman's membrane and anterior corneal fibers up to the depth of approximately 120 to 130 µm. After enhancement, clinical outcomes were analyzed for a mean period of 36 months (range: 14 to 57 months). RESULTS: Four eyes of 3 patients (mean age: 29 years) underwent enhancement with BMR for a significant residual refractive error of +2.25 diopters (D) spherical equivalent following FILI for high hyperopia (mean spherical equivalent: +7.00 D). After BMR, the residual refraction reduced to +0.31 D, resulting in improvement in uncorrected distance visual acuity from 0.55 to 0.33 logMAR. The mean front keratometry values increased from 46.20 to 49.30 D, and the mean back keratometry values increased from -5.90 to -6.30 D following BMR, the latter returning to the baseline (pre-FILI) value of -6.30 D. An increase in Q-value with a corresponding increase in higher order aberrations was observed. Corneal biomechanics indicated reduction of stiffness and other parameters after enhancement. No intraoperative or postoperative complications were noted. CONCLUSIONS: BMR may be an effective technique for enhancement of residual hyperopia following tissue addition techniques such as FILI. BMR may reverse the posterior curvature changes, negating the steepening effect of the anterior cornea following tissue addition, potentially aiding in the enhancement. [J Refract Surg. 2022;38(2):134-141.].

Incidence of Ectasia After SMILE From a High-Volume Refractive Surgery Center in India.

PURPOSE: To report the incidence of ectasia after small incision lenticule extraction (SMILE) in a high-volume refractive surgery center in India. METHODS: To derive the incidence of ectasia after SMILE, all eyes that underwent SMILE or SMILE Xtra (SMILE combined with prophylactic accelerated corneal cross-linking) from November 2012 to August 2019 were retrospectively analyzed. Furthermore, these cases were classified as being "normal" or "borderline" based on certain predefined criteria. Only eyes with a minimum follow-up of 12 months were included. RESULTS: Of the total 7,024 eyes analyzed, 6,619 eyes underwent SMILE, of which 10 eyes developed ectasia at a mean interval of 21.3 months, making the incidence of ectasia after SMILE 0.15%. Of these 10 eyes with ectasia, 2 eyes had normal preoperative topography, whereas the remaining 8 eyes were borderline as per the predefined criteria. Retrospective data analysis revealed that 6,025 of 7,024 eyes were normal and thus suitable for a standard SMILE procedure, whereas 999 eyes were borderline, of which 594 eyes underwent SMILE and 405 eyes underwent SMILE Xtra. The incidence of ectasia in borderline eyes undergoing SMILE was 0.80% (8 of 999) versus 0% (none) for borderline eyes undergoing SMILE Xtra (chi square, P < .05). CONCLUSIONS: The incidence of ectasia after SMILE in the early postoperative period was 0.15%, with borderline eyes accounting for most cases. Borderline eyes treated with SMILE Xtra did not progress to ectasia, potentially suggesting a protective role of simultaneous CXL. [J Refract Surg. 2021;37(12):800-808.].

Clinical Outcomes, Contrast Sensitivity, Reading Performance and Patient Satisfaction Following Bilateral Implantation of AT LARA 829MP EDoF IOLs.

PURPOSE: To evaluate the visual outcomes, contrast sensitivity, reading performance and patient satisfaction after bilateral implantation of AT LARA extended depth of focus (EDoF) intraocular lenses (IOLs). METHODS: Patients undergoing phacoemulsification for age-related cataract and satisfying the eligibility criteria underwent bilateral implantation with AT LARA EDoF IOLs (Carl Zeiss Meditec, Jena, Germany). At follow-up visits of 1, 3, 6 and 12 months, binocular uncorrected and corrected distance, intermediate and near visual acuity, reading performance, defocus curve, contrast sensitivity and patient satisfaction for dysphotopsia and spectacle independence were evaluated. RESULTS: A total of 60 eyes from 30 patients with a mean age of 65.40±7.71 years were included in the study. At 12 months, 83% of patients (n=25) had binocular cumulative uncorrected distance visual acuity (UDVA) of 20/20 or better. Postoperative spherical equivalent refraction accuracy was within ±0.50 D for 95% of eyes (n=57) and refractive cylinder accuracy was within ≤0.50 D in 95% of eyes (n=57). The mean binocular uncorrected near visual acuity (UNVA) was 0.16±0.09 logMAR, and the mean uncorrected intermediate visual acuity (UIVA) at 60 and 80 cm was 0.01±0.09 and 0.03±0.08 logMAR, respectively, at 12 months. Reading speeds at 40, 60 and 80 cm showed improvement over time. No patient had complaints of severe dysphotopsia and none of the patients required glasses for any activity. No eye underwent YAG-laser capsulotomy for significant posterior capsule opacification at the end of mean follow-up. CONCLUSION: In our limited experience of 30 patients at 12 months, AT LARA EDoF IOLs resulted in excellent visual outcomes for uncorrected distance, intermediate and near visual acuity. The incidence of dysphotopsia and spectacle dependence was low, resulting in good patient satisfaction. TRIAL REGISTRY: CTRI/2020/08/027105 (www.ctri.nic.in).